Method and apparatus for treating an ocular disorder

ABSTRACT

Embodiments of the claimed invention are directed to the treatment of glaucoma (or conditions of elevated intraocular pressure) using a novel ab interno trabeculotomy procedure that uses a flexible device. At least one advantage of the present method is that it does not require a conjunctival or scleral incision, which in turn improves patient recovery time and healing.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 14/376,235filed Aug. 1, 2014, which is a national stage (35 U.S.C. § 371)application of PCT/US2012/062332 filed Oct. 27, 2012, which claimspriority to U.S. Provisional Application Ser. No. 61/594,502 filed onFeb. 3, 2012, all of which are incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

The present invention generally relates to improved systems and methodsfor the reduction of elevated pressure in the human eye. Moreparticularly, the present invention relates to the treatment of glaucomaby an ab interno method for trabeculotomy utilizing a device insertedinto Schlemm's canal and advanced along Schlemm's canal.

BACKGROUND OF THE INVENTION

About two percent of the adult population in the United States hasglaucoma. Glaucoma is a group of eye diseases that causes pathologicalchanges in the optic disk and corresponding visual field loss resultingin blindness if untreated. Intraocular pressure elevation is the majoretiologic factor in all glaucomas.

In most glaucomas the source of resistance to outflow is in thetrabecular meshwork. The tissue of the trabecular meshwork allows the“aqueous” to enter Schlemm's canal, which then empties into aqueouscollector channels in the posterior wall of Schlemm's canal and theninto aqueous veins. The “aqueous” or aqueous humor is a transparentliquid that fills the region between the cornea at the front of the eyeand the lens. The aqueous humor is constantly secreted by the ciliarybody around the lens, and thus there is a continuous flow of the aqueoushumor from the ciliary body to the eye's front chamber. The eye'spressure is determined by a balance between the production of aqueousand its exit through the trabecular meshwork (major route) or viauveoscleral outflow (minor route). The trabecular meshwork is locatedbetween the outer rim of the iris and the internal periphery of thecornea. The portion of the trabecular meshwork adjacent to Schlemm'scanal causes most of the resistance to aqueous outflow (juxtacanalicularmeshwork).

Glaucoma is grossly classified into two categories: closed-angleglaucoma and open-angle glaucoma. The closed-angle glaucoma is caused byclosure of the anterior angle by contact between the iris and the innersurface of the trabecular meshwork. Closure of this anatomical angleprevents normal drainage of aqueous humor from the anterior chamber ofthe eye. Open-angle glaucoma is any glaucoma in which the angle of theanterior chamber remains open, but the exit of aqueous through thetrabecular meshwork is diminished.

All current therapies for glaucoma are directed at decreasingintraocular pressure. This is initially done by medical therapy withdrops or pills that reduce the production of aqueous humor or increasethe outflow of aqueous. However, these various drug therapies forglaucoma are sometimes associated with significant side effects, such asheadache, blurred vision, allergic reactions, and potential interactionswith other drugs. When the drug therapy fails, surgical therapy is used.Surgical therapy for open-angle glaucoma consists of laser(trabeculoplasty), trabeculectomy and aqueous shunting implants afterfailure of trabeculectomy or if trabeculectomy is unlikely to succeed.

Trabeculectomy is a surgical procedure used in the treatment of glaucomato relieve intraocular pressure by creating a pathway for aqueous fromthe anterior chamber to the sub-conjunctival space. It is the mostcommon glaucoma surgery performed and creates a bypass route for theaqueous humor to drain aqueous humor from within the eye to underneaththe conjunctiva where it is absorbed. Additionally, glaucoma drainagedevices are also frequently used for the treatment of glaucoma. Thesedevices utilize hardware and a tube to shunt aqueous humor from withinthe eye to underneath the conjunctiva. Both trabeculectomy and drainagedevice implantation requires dissection of the external sclera andconjunctiva of the eye.

All of the currently known and performed embodiments and variations ofglaucoma surgery have numerous disadvantages and moderate success rates.These modalities are currently limited by wound healing processes at thesite of surgery, which are further accelerated in cases that haveundergone previous conjunctival or scleral surgery. The wound healingand scarring process associated with glaucoma surgery involving theconjunctiva and sclera also limits the ability to perform subsequentglaucoma surgery in the same location. Therefore, there is a greatclinical need for the treatment of glaucoma by a method that would befaster, safer and less expensive than currently available modalities,which involve either substantial trauma to the eye and require greatsurgical skill by creating a hole over the full thickness of the scleraor cornea-scleral junction to create a flow path from the anteriorchamber into the subconjunctival space or by placing a permanent deviceinto the eye.

The morbidity associated with trabeculectomy consists of failure (10-15%per year), infection (a lifelong risk about 2-5%), choroidal hemorrhage(1%, a severe internal hemorrhage from pressure too low resulting invisual loss), cataract formation, and hypotony maculopathy (potentialvisual loss from pressure too low).

Thus, it would be desirable to develop a surgical system and method fortreating glaucoma that does not require a conjunctival and scleralincision, which in turn would hasten patient healing and improverecovery time. Such a procedure would also spare the sclera andconjunctival tissues, allowing ab-externo surgery at a later date ifneeded.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the structure of an eye in cross-section and its variousparts;

FIG. 2 shows the creation of an incision in the trabecular meshwork ofthe eye and the insertion of a device into the incision in accordancewith an embodiment of the invention;

FIG. 3 shows the advancement of a device within Schlemm's canal inaccordance with an embodiment of the invention; and

FIG. 4 shows the completion of the trabeculotomy in accordance with anembodiment of the invention.

SUMMARY OF THE INVENTION

An embodiment of the invention is directed to an apparatus for treatingan ocular disorder in a patient, the apparatus comprising a device,wherein said device comprises a body having a proximal section and adistal section, the body having a maximum cross-sectional dimensionsized to allow insertion of the body through an opening in the eye; anda lumen extending through the body from the proximal section to thedistal section, wherein the device is configured for ab internoinsertion of the device through an opening in the eye and sized toextend into Schlemm's canal; and wherein said device has sufficientlength between the proximal section and distal section such that, uponinsertion, at least a portion of the proximal section of themicrocatheter is disposed within Schlemm's canal and at least a portionof the distal section of the microcatheter extends into and along aportion of an outflow pathway of the eye.

A further embodiment of the invention is directed to a method forperforming a trabeculotomy ab interno, the method comprising the stepsof, making at least one corneal incision, placing a surgical instrumentwith a cutting edge through the corneal incision, making an incisioninto the trabecular meshwork to access the lumen of Schlemm's canal,placing the distal end of a device into the anterior chamber, advancingthe device within Schlemm's canal, pulling the distal tip of the deviceinto the anterior chamber, applying tension to the device within thecanal by applying tension between the ends of the device withinSchlemm's canal thereby rupturing the trabecular meshwork in the areacannulated by the device, and withdrawing the device through the cornealincision.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The 360-degree ab externo suture trabeculotomy has been the goldstandard for the treatment of congenital glaucoma for the past severaldecades. This technique has also been used successfully in the treatmentof juvenile open angle glaucoma as well as various other open angleglaucomas. In a 360-degree trabeculotomy, the goal of this procedure isto rupture or tear through the trabecular meshwork to open the entirelength of Schlemm's canal to directly communicate with the anteriorchamber, thereby removing the resistance to aqueous outflow of thetrabecular meshwork and reducing intraocular pressure. This isaccomplished by passing a device 360 degrees within Schlemm's canal.Tension is placed on the suture or catheter until it is pulled throughthe inner wall of the canal, the trabecular meshwork, and into theanterior chamber. This 360-degree procedure is carried out ab externo,through a conjunctival incision and partial thickness scleral dissectionto expose Schlemm's canal. When the full 360 degrees of Schlemm's canalcannot be treated, a partial trabeculotomy of greatest length is usuallyperformed, which also provides significant increase in aqueous outflowand reduction in intraocular pressure.

An embodiment of the claimed invention is directed to an ab internoapproach to a trabeculotomy utilizing a device such as a microcatheter,a suture, or other device that can be inserted into Schlemm's canal. Inembodiments of the invention, the device that is used is flexible innature. In embodiments of the invention, the lumen of Schlemm's canal isaccessed from the anterior chamber without the need or requirement fordissection of the sclera or conjunctiva. This is possible because theinner wall of Schlemm's canal, the trabecular meshwork, is directlyadjacent to the anterior chamber.

FIG. 1 shows the structure of the eye in cross-section. The lens (1),iris (2) and cornea (3) are shown. Also shown is the location of thetrabecular meshwork (4) and Schlemm's canal (5).

In an embodiment of the invention, a goniotomy or incision of Schlemm'scanal is created using a microsurgical instrument from within theanterior chamber with the aid of a gonioscopy prism or other imagingdevice to visualize the anterior chamber angle. As shown in FIG. 2, anincision (6) is made in the trabecular meshwork (4) using a cuttinginstrument (not shown) from within the anterior chamber. A device (8) isused to cannulate the goniotomy opening, i.e., the device is insertedinto the goniotomy opening, and enter Schlemm's canal (5).

As shown in FIG. 3, after entry into Schlemm's canal (5), the device (8)is advanced along the canal. The advancement of the device (8) isfacilitated using an instrument (7) that grips the device and advancesthe device along a path within the canal (9). An instrument such as aforceps, or more specifically an ocular microforceps (7) is used toinsert and advance the device (8) into and within Schlemm's canal.

In an embodiment of the invention, an incision is made through thecornea (10) for insertion of the device (8).

In an embodiment of the invention, the device (8) is advanced withinSchlemm's canal until the distal end of the device is near the initialgoniotomy incision, i.e., 360 degrees. The instrument (7) that is usedto insert and advance the device (8) through Schlemm's canal is used toretrieve the distal end of the device (8) as shown in FIG. 4. Tractionor tension is then placed on the proximal and distal ends of the deviceusing the instrument (7) to pull the device into the anterior chamber,thus rupturing the trabecular meshwork, exposing Schlemm's canal andthereby create a 360-degree trabeculotomy ab interno as shown in FIG. 4(11).

Due to scarring or malformations of Schlemm's canal, it may not alwaysbe possible to advance the device around the complete circumference ofthe canal. Thus, in certain embodiments of the invention, thetrabeculotomy procedure using the inventive method may also be performedon a portion of Schlemm's canal as a partial trabeculotomy by advancingthe device partially for one or more clock hours through Schlemm'scanal, and then retrieving the distal end through the trabecularmeshwork via an incision (goniotomy). Applying tension to one or bothends of the device would then form a partial trabeculotomy between thegoniotomy (point of incision and insertion of device) and the distalend.

In certain embodiments of the invention, the trabeculotomy may continueto be applied to the untreated portion of Schlemm's canal by cannulatingthe remaining portion of the canal and repeating the partialtrabeculotomy procedure. For example, the entire canal could be treatedby two 180 degree procedures, three 120 degree procedures or any similarcombination. In highly compromised or diseased eyes, only a portion ofSchlemm's canal may be cannulated and a partial trabeculotomy performedusing the technique set forth herein.

In certain embodiments of the invention, the device that is used tocannulate Schlemm's canal comprises a flexible device that is of asuitable size, shape and thickness to enter and cannulate thecircumference of the canal. The meridional diameter of Schlemm's canalranges from 200 to 250 microns and has been reported as large as 350 to500 microns. The canal has a reported length of 36 mm with somevariation due to the size of the eye or from disease conditions. Forcannulating Schlemm's canal, the device is preferred to be fromapproximately 10 to 500 microns in diameter and length of at least 36mm. To facilitate advancement of the device in the canal, the distal tipmay be rounded and the device may have a lubricious coating on at leastthe distal end. The device may comprise a flexible metal, polymer, ornatural material. The device may be straight, or also incorporate acurve at the distal end. The curve may be greater than or approximatethe curvature of Schlemm's canal. In certain embodiments of theinvention, the curved tip has a radius ranging from 2 to 4 mm. Thedevice may also comprise a lumen such as a microcatheter to allow thedelivery of materials from or to the distal tip. In addition, the devicemay have markings along the length of the device or at the tip to helpvisualization the device within the canal.

In an embodiment of the invention, the device that is used in methods ofthe invention comprises a tip which emits light to allow the tiplocation to be visualized through the trabecular meshwork from withinthe eye, as well as through the sclera and conjunctiva from outside ofthe eye to provide guidance for advancement within the canal. Although alight emitting device may be desirable, it is not required for thisprocedure.

The primary advantage of the presently disclosed ab interno approach isthat it does not require a conjunctival or scleral incision. As such, noscleral dissection is required and there is no risk for a bleb on thesurface of the eye. Additionally, this approach spares the entireconjunctiva and sclera, which is ideal in the event that traditionalglaucoma surgery or other eye surgery is needed in the future.Post-operatively, the recovery time is at least on par with patients whohave undergone a 360-degree trabeculotomy ab externo, however, initialexperience suggests it is less due to the lack of conjunctival andscleral dissection.

In an embodiment of the invention, a lid speculum is placed in the eyeand a gonioprism (or other anterior chamber angle imaging device) isplaced on the eye. The surgical microscope is tilted so that theanterior chamber angle at the goniotomy site can be appreciated. Inaccordance with the embodiment of the invention, the ciliary bodystructures, the trabecular meshwork, as well as the scleral spur in theanterior chamber angle are identified.

A tangential paracentesis incision is made in the cornea, through whichan intraocular composition is injected in order to constrict the pupiland facilitate access to the trabecular meshwork from the anteriorchamber. In certain embodiments of the invention, the composition thatis used comprises acetylcholine. Examples of such compositions includeMiochol-E® and Miostat®.

In accordance with an embodiment of the invention, a surgicalviscoelastic such as a solution of sodium hyaluronate is injected intothe anterior chamber of the eye to maintain or enlarge the chamberdimensions. Examples of the composition include, but are not limited toHealon®, which is a non-pyrogenic solution of a highly purified highmolecular weight fraction of sodium hyaluronate extracted from animaltissue, dissolved in a physiological buffer. The average molecularweight of the sodium hyaluronate in Healon is approximately 4 millionDaltons. Following the viscoelastic injection, a clear corneal incisionof approximately 1-3 mm in width is made approximately 3 clock hoursaway from the paracentesis using a microsurgical blade. A differentmicrosurgical blade is inserted into the corneal incision and used toform a goniotomy by incising the trabecular meshwork in the regiondirectly across the eye from the corneal incision to create directaccess to the lumen of Schlemm's canal. The device is inserted into theparacentesis and the gonioprism is placed on the eye to visualize thedistal end of the device approaching the angle structures in the incisedregion of the canal. Surgical forceps are then inserted into the eyethrough the clear corneal incision. These are used to grasp the deviceand direct the distal part of the device into the incision of Schlemm'scanal. The gonioprism (or other device used to image the anteriorchamber angle) is placed in or on the eye and allows visualization ofthis procedure. The device is threaded into Schlemm's canal through theincision created by the microsurgical blade.

The positioning of the device is confirmed through an external view ofthe eye. In an embodiment of the invention, if a lighted microcatheteris used to cannulate Schlemm's canal, the transillumination of the lightat the distal end of the catheter in Schlemm's canal can be visualizedinternally or externally. If a lighted microcatheter is not used, thenthe device is visualized directly internally or externally without theaid of a lighted catheter.

In certain embodiments of the invention, a microcatheter may be used tocannulate Schlemm's canal. In such a case, a viscoelastic may beinjected into the catheter during advancement in Schlemm's canal toprovide lubrication and reduce the force needed for advancement. Theinjected viscoelastic may also aid the procedure by filling thedownstream collector channels and reducing blood reflux into theanterior chamber of the eye.

Following the cannulation of Schlemm's canal, the surgical forceps areplaced back into the eye with a gonioprism on the eye for visualizationand the device is advanced around the canal. The distal end of thedevice is retrieved with the surgical forceps and removed from the eyethrough the clear corneal incision. This creates a 180-degreetrabeculotomy in the inferior quadrant. The 360-degree trabeculotomy isthen completed by grasping and applying tension to the proximal end tofinish the trabeculotomy 180 degrees superiorly. The device is thenremoved from the eye through the paracentesis.

In accordance with an embodiment of the invention, an endoscopic cameramay be used to visualize the surgical procedure within the anteriorchamber to facilitate proper placement and use of the instruments withinthe anterior chamber. Upon completing the trabeculotomy, blood reflux istypically noted from the canal. Surgical viscoelastic is injected intothe eye to reform the chamber and maintain adequate pressure with theadditional goal of blocking the flow of blood. A single suture such asan interrupted 10-0nylon suture is placed through the clear cornealincision if needed. Prior to tying the suture, the previously injectedsurgical viscoelastic is irrigated out of the anterior chamber, as isblood that has refluxed into the anterior chamber. The suture is thentied off and the eye pressurized by injection of balanced salt solutionto a pressure of at least 10-15 mmHg by palpation.

An intraocular composition such as Miochol-E® is injected into the eye,followed by a subconjunctival injection of prophylactic antibiotic andan anti-inflammatory agent such as a corticosteroid that is administeredinferiorly. It is further noted that the wounds are watertight and thepressure is slightly above the physiologic state to minimize the chanceof bleeding.

From the foregoing description, it should now be appreciated that anovel approach for the surgical treatment of glaucoma has been disclosedfor releasing excessive intraocular pressure. While the invention hasbeen described with reference to a specific embodiment, the descriptionis illustrative of the invention and is not to be construed as limitingthe invention. Various modifications and applications may occur to thosewho are skilled in the art, without departing from the true spirit andscope of the invention, as described by the appended claims.

What is claimed is:
 1. A method for performing a trabeculotomy of an eyeab interno, the method comprising the steps of: making an incision in acornea to access a trabecular meshwork of an eye; making an incision inthe trabecular meshwork to access a lumen of a Schlemm's canal of theeye; advancing a distal tip of a device into the Schlemm's canal;pulling the distal tip of the device into an anterior chamber of theeye; and applying tension to the device within the Schlemm's canal torupture the trabecular meshwork in an area cannulated by the device. 2.The method of claim 1, wherein the advancing comprises advancing thedevice along a full circumference of the Schlemm's canal.
 3. The methodof claim 1, wherein the advancing comprises advancing the device alongthe Schlemm's canal for a portion of the Schlemm's canal.
 4. The methodof claim 1, wherein the device comprises a lumen to inject fluid duringcannulation of the Schlemm's canal.
 5. The method of claim 1, whereinthe device comprises a lighted tip to facilitate visualization of alocation of the lighted tip during cannulation of the Schlemm's canal.6. The method of claim 1, wherein the device comprises a curved tip. 7.The method of claim 6, wherein the curved tip has a radius ranging from2 to 4 mm.
 8. The method of claim 1, further comprising making a secondcorneal incision to retrieve the distal tip of the device.
 9. A methodfor performing a trabeculotomy of an eye ab interno, the methodcomprising the steps of: making an incision in a cornea to access atrabecular meshwork of an eye; making an incision in the trabecularmeshwork to access a lumen of a Schlemm's canal of the eye; advancing adistal tip of a device into the Schlemm's canal; and injecting aviscoelastic into the Schlemm's canal.
 10. The method of claim 9,further comprising observing a light emitted by the distal tip as thedevice is advanced into the Schlemm's canal.
 11. The method of claim 9,wherein the incision in the cornea is made at a position ofapproximately 3 clock hours from a paracentesis for an injection offluid into the eye.
 12. The method of claim 9, wherein the advancingcomprises advancing the device along a full circumference of theSchlemm's canal.
 13. The method of claim 9, further comprising injectingadditional viscoelastic into the eye to pressurize the eye.
 14. Themethod of claim 9, wherein the incision in the trabecular meshwork isextended as the distal tip of the device is advanced into the Schlemm'scanal.
 15. A device for treating an ocular disorder in a patient, thedevice comprising: a body comprising: a first end and a second end: across-sectional dimension sized to allow insertion of the body into aSchlemm's canal of an eye; and a lumen that extends through the bodyfrom the first end to the second end.
 16. The device of claim 15 whereinthe cross-sectional dimension is between 10 and 500 microns.
 17. Thedevice of claim 15, wherein the first end of the body is rounded andcomprises a lubricious coating.
 18. The device of claim 15, wherein thefirst end of the body comprises a curve with a radius between 2 mm and 4mm.
 19. The device of claim 15, wherein the body comprises markingsalong a length of the body to provide a visualization of the device whenthe device is positioned within the Schlemm's canal.
 20. The device ofclaim 15, wherein the body comprises a fiber optic coupled to a lightemitting device.